510(k) K895866

DIRD INGANT O2 (BIO 2 HOOD) by Bird Products Corp. — Product Code BYL

K895866 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "DIRD INGANT O2 (BIO 2 HOOD)". The FDA issued a decision of Substantially Equivalent on October 27, 1989. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Bird Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
October 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Oxygen
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type